Offset alignment device

ABSTRACT

The present invention relates to an offset alignment device that is adjustable in the lateral or medial direction, the anterior or posterior direction and rotatably adjustable at a single interface between the two pieces of the present invention. A first piece is provided having a body with a central axis. A positioner is on the first side of the body. A second piece is provided having a central axis and a flange. A side wall upstands from the flange to define an opening. The positioner can be selectably received within the opening while the central axis of the first piece remains parallel to the central axis of the second piece. The pieces are lockable in place with respect to each other at the selected offset alignment and rotational orientation.

This application is a continuation in part application of pending UnitedStates patent application filed on Jun. 25, 2004 and having applicationSer. No. 10/876,349, the contents of which are hereby incorporatedherein by reference.

BACKGROUND OF THE INVENTION

1. The present invention relates to an offset alignment device and moreparticularly an alignment device that is adjustable in both the lateralor medial direction and the anterior or posterior direction, and alsorotatably connectable, at a single interface between the two pieces ofthe present invention.

2. Description of the Related Art

Sometimes, due to accidents, health problems, birth defects, etc.,people 5 need to have a limb 6 amputated. The amputated limb 6terminates in a stump 7. In general, a prosthetic component such as asocket 10 can be formed for a particular stump 7. Sockets 10 are wellknown in the art, and each socket 10 has an end 11 and a central axis12.

Fortunately for people requiring a prosthetic limb, much advancement hasbeen made in the field of prosthetic limbs. Patients now have manychoices, including endoskeletal and exoskeletal prosthetic limbs. Thepresent invention relates to endoskeletal prosthetic limbs. That is,limbs comprised of structural components and an optional aesthetic outershell.

Turning now to FIG. 1, the components of a typical prosthetic limb setup30 are shown. A conventional four hole adapter 20 having a central axis21 that runs centrally through the component is shown. In somesituations, the four hole adapter 20 cannot be positioned centrally uponthe socket 10. Even though the central axis 21 of the adapter 20 isparallel to the central axis 12 of the socket 10, it is offset therefrom. Specifically, the adapter central axis 21 can be offset from thesocket central axis 12 in the lateral or medial direction 15 and 16 aswell as in the anterior or posterior direction 18 or 19 by a totaloffset distance delta. A conventional pylon 25 with a fixed receiver 26and central axis 27 is also provided. It is preferable that the pyloncentral axis 27 be centrally aligned with the socket central axis 12, toensure maximum comfort and stability of the prosthetic limb. Thisalignment is further preferred because a person's gait may be adverselyaffected if the pylon central axis 27 is out of central alignment withthe socket central axis 12 and the person may experience unnecessarymuscle strain and fatigue. Yet, as shown, it can be impossible toachieve this preferred socket central axis 12 and pylon central axis 27alignment when the conventional four hole adapter 20 is offset from thesocket.

Similar problems also arise when the prosthetic components are attachedto the lower knee joint (not shown) as opposed to a socket 10.

Turning now to FIG. 2, a modified four hole adapter 35 is shown. Theadapter 35 is exemplary of the adapter shown in U.S. Pat. No. RE 36,521to Hiemisch. The modified four hole adapter 35 has a pyramid with analignment axis 36 running there through. Adapter 35 also has a centralaxis 37. The alignment axis 36 and central axis 37 are parallel andoffset from one another by a fixed distance and orientation. The fourholes are arranged in a square pattern, such that the adapter 35 canalign with its adjacent component in one of four positions by rotatingthe adapter 35 around its central axis 37 in relation to the adjacentcomponent. Therefore, the alignment axis 36 can be selectively orientedto one of four distinct orientations relative to the central axis or itsadjacent component.

Even though the modified adapter 35 of the Hiemisch patent may work wellfor its intended purposes, it is not without drawbacks. For example,while the component is capable of being reoriented with respect to anadjacent component, there are only a limited number of possibleorientations. Specifically, only four orientations are possible.Further, the adapter 35 is only useful when the offset amount delta isat an appropriate distance and angle from the socket central axis 12 ina plane defined by the lateral or medial direction 15 and 16 and theanterior or posterior direction 17 and 18. In many prosthetic limbs, theend of the socket 11 is not offset by an amount that can be overcomewith adapter 35. Therefore, incorporation of the adapter 35 into theprosthetic limb may not work to fully realize its intended results.

A further existing product is made by Hosmer Dorrance Corporation underthe name Spectrum Alignment System. To make adjustments in both thelateral or medial direction and also the anterior or posteriordirection, a minimum of three major components is required. The firstcomponent is a four hole plate with a male dovetail protruding therefrom along a first axis. The second component is an adapter with afemale dovetail receiver for mating with the male dovetail of the firstcomponent, and with a male dovetail that is on the opposed side of theadapter and that is aligned generally perpendicular to the femaledovetail receiver. The third component has a female dovetail receiver onits first side for mating with the male dovetail of the second componentand a standard pyramid on the opposed side.

To make adjustments with the Spectrum Alignment System, side shiftscrews are provided. Each side shift screw has a head with a rib thatrests in a groove in the female dovetail section. The threaded end ofthe screw is received within a hole in the male dovetail section. Thescrew head remains laterally stationary relative to the female dovetailsection as the screw is twisted. However, the male dovetail sectiontranslates towards or away from the screw head as the screw is twisted,depending on which way the screw is twisted. Three screws and ballbearings are shown to guide the male end within the female end. The ballbearings are anti-friction devices that reduce friction between thefemale and male dovetail sections, which encourage movement of the maleend within the female end when the side shift screw is twisted.

The structural integrity of the dovetail connection is determined solelyby the strength of the ribs on the screw head. If the screw head fails,the entire component could fail. These components may therefore be lessthan optimally strong. Also, given that three components are necessaryto effectuate the intended adjustment, this system is undesirably overlycomplicated.

A still further existing system is shown in U.S. Pat. No. 5,549,710 toVera et al. This patent is entitled system for assembling two componentsof a prosthesis in a plurality of adjustable positions. The Vera systemhas a projecting part integral with one of the components, and a hollowpart formed into the second component. As shown in FIGS. 2 and 3 of theVera patent, the projecting part of the first component is not able tofully move within the hollow part of the second component. This isbecause the screws would engage the base of the hollow part instead ofthe lateral flanks of the projecting part after the projecting partmoves a short distance from center and prior to the projecting partmoving near the side walls of the hollow part. Further, an embodiment isshown where the projecting part can be twisted and held in place with ascrew, as shown in FIG. 11. Such an arrangement is less structurallysecure than an integrally formed component.

A still further device yet is shown in UK patent application 2,141,345with applicant Landstingens Inkopscentral LIC (Sweden) entitled “Anadjustable connection for connecting adjoining parts of an artificiallimb.” Screws are provided for locking first and second couplingcomponents together. The first and second coupling components beardirectly against each other along mutually co-acting support surfaces.The screws are arranged in an annular flange one element that encirclesthe other coupling element. Yet, the annular flange does not directlycontact the second coupling element.

Thus there exists a need for an offset alignment device that solvesthese and other problems.

SUMMARY OF THE INVENTION

The present invention relates to an offset alignment device that isadjustable in the lateral or medial direction and the anterior orposterior direction, and is also rotatably connectable, at a singleinterface between the two pieces of the present invention.

This is accomplished in one embodiment by providing a first piece havinga body with a central axis through the body. The body has two sides. Apositioner is on the first side of the body. A dome with a pyramid is onthe second side of the body. A second piece, having a central axis and aflange is also provided. Four walls upstand from the flange to define anopening.

The first and second pieces of the present invention are selectablyoffsetable at a single interface in both the lateral or medial directionand in the anterior or posterior direction. The first piece and secondpiece co-act so that the positioner can be selectably received andpositioned within the opening. The body of the first piece rests on thetop of the walls of the second piece to provide stability and ensurethat the central axis of the first piece remains parallel to the centralaxis of the second piece.

In a second embodiment, the positioner has more than four faces so thatthe first piece can be rotated and locked in place relative to thesecond piece in less than ninety degree increments. In a thirdembodiment, the positioner has a generally round profile so that thefirst piece can be rotated and locked in place relative to the secondpiece in an infinite number of positions.

It is a goal of the present invention to have only limited complexity.This is accomplished by having only two major pieces that are adjustablein both the lateral or medial direction and the anterior or posteriordirection at a single interface.

It is a further goal of the present invention to have a prostheticcomponent that is precisely adjustable. This is accomplished byincorporating screws in the preferred embodiment that can preciselyadjust alignment of the pieces in both the lateral or medial directionand in the anterior or posterior direction, and also by allowing onepiece to be rotatably lockable relative to the second piece.

A further goal of the present invention is to provide maximum comfortand stability to a person with a prosthetic limb. This is accomplishedby allowing the prosthetic limb to be properly aligned to enable theperson to have a correct gait.

A still further goal of the present invention is to provide a prostheticcomponent that is strong enough to withstand daily stresses that it issubject to. This is accomplished in the preferred embodiments by havingthe body of the first piece rest on the wall or walls of the secondpiece to ensure proper alignment of the first piece central axis and thesecond piece central axis, and by having multiple screws to forceablykeep the positioner within the opening.

It is a goal of some embodiments of the present invention to allow thefirst component to be rotated relative to the second component in lessthan ninety degree increments, and in some embodiments an infinitenumber of increments.

Other advantages, benefits, and features of the present invention willbecome apparent to those skilled in the art upon reading the detaileddescription of the invention and studying the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded side view of existing prosthetic components.

FIG. 2 is a top view of an existing rigid and offset four hole adapter.

FIG. 3 is a side view of an embodiment of the present invention.

FIG. 4 is an exploded side view of the embodiment shown in FIG. 3

FIG. 5 is a top view of an embodiment of a piece of the presentinvention.

FIG. 6 is a side view of the piece shown in FIG. 5.

FIG. 7 is a bottom view of the piece shown in FIG. 5.

FIG. 8 is a cross-sectional view of the piece shown in FIG. 5 takenalong line 8-8 in FIG. 5.

FIG. 9 is a top view of an embodiment of a second piece of the presentinvention.

FIG. 10 is a side view of the piece shown in FIG. 9.

FIG. 11 is a cross-sectional view of the piece shown in FIG. 9 takenalong line 11-11 in FIG. 9.

FIG. 12 is a side view of an embodiment of the present invention similarto FIG. 3, but instead showing the first piece and second piece in anoffset alignment.

FIG. 13 is a cross-sectional view of the embodiment shown in FIG. 12taken along line 13-13 in FIG. 12.

FIG. 14 is a top view of the embodiment shown in FIG. 12.

FIG. 15 is an exploded side view of an embodiment of the presentinvention in relation to other prosthetic components.

FIG. 16 is a side view of an embodiment of the present invention wherethe first and second pieces are offset to overcome a natural offset ofthe remainder of the prosthetic components.

FIG. 17 is a side view of an alternative embodiment of the presentinvention.

FIG. 18 is an exploded side view of the alternative embodiment shown inFIG. 17.

FIG. 19 is a side view of a piece of the alternative embodiment shown inFIG. 17.

FIG. 20 is a cross-sectional view of the piece shown in FIG. 19 takenalong line 20-20.

FIG. 21 is a bottom view of a second piece of the alternative embodimentshown in FIG. 17.

FIG. 22 is a side view of the piece shown in FIG. 21.

FIG. 23 is a cross-sectional view of the piece shown in FIG. 22 takenalong line 23-23.

FIG. 24 is a side view of the embodiment shown in FIG. 17, but showingthe first piece and second piece in an offset alignment.

FIG. 25 is cross-sectional view of the embodiment shown in FIG. 24 takenalong line 25-25.

FIG. 26 is a top view of the embodiment shown in FIG. 24.

FIG. 27 is an exploded side view of an additional alternative embodimentof the present invention.

FIG. 28 a cross-sectional view of the piece shown in FIG. 27 taken alongline 28-28.

FIG. 29 is a bottom view of the second piece of the embodiment shown inFIG. 27.

FIG. 30 is a cross-sectional view of the piece shown in FIG. 31 takenalong line 30-30.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the invention will be described in connection with severalpreferred embodiments, it will be understood that it is not intended tolimit the invention to those embodiments. On the contrary, it isintended to cover all alternatives, modifications and equivalents as maybe included within the spirit and scope of the invention as defined bythe appended claims.

According to one embodiment of the present invention, a four holealignable device 50 is provided. The device, or prosthetic component, isconnectable to an adjacent prosthetic component, such as a socket 10 ora lower knee joint. The device 50 is also connectable to a prostheticcomponent, such as a conventional pylon 25 or other type of componenthaving a pyramidal receiver. However, it will be understood that theseadjacent prosthetic components are exemplary in nature, and that thepresent invention is not limited for use therewith. The four holealignable device 50 of the present invention is preferably made ofTitanium alloy. However, other materials may be used without departingfrom the broad aspects of the present invention. The present inventionis preferably made in a Computer Numerical Controlled machining process.

Turning now to FIGS. 3 and 4, it is shown that the four hole alignabledevice 50 is comprised of two major pieces 60 and 90, respectively.

The first piece 60, or component, is shown in further detail in FIGS.5-8. The first piece 60 has a body 61. Body 61 is preferably a flatflange that lies in a plane and that is disk shaped. Body 61 has a firstside 65 and an opposed second side 75. A central axis 80 runs throughthe first piece in a direction generally perpendicular to the body 61.

A positioner 66 is on the first side 65 of the body 61. The positioner66 is preferably a protrusion that is formed integral with the firstside. Further, the positioner 66 preferably has the shape of a foursided pyramid with faces 67, 68, 69 and 70. Face 67 opposes face 69, andface 68 opposed face 70. The pyramid has an outer surface that lies in aplane that is generally parallel to the plane of the body.

A dome 76 with a pyramid 77 is preferably on the second side 75 of thebody 61 of the first piece 60. The dome 76 and pyramid 77 are preferablyconventional in nature, and are adapted to be connected to an adjacentprosthetic component. In the preferred embodiment, the dome 76 andpyramid 77 are formed integral with the body 61. It is understood thatan alternative connector can be used without departing from the broadaspects of the present invention.

Turning now to FIGS. 9-11, a second piece 90 is shown in further detail.The second piece 90, or component, has a flange 91. The flange 91 ispreferably flat, and lies in a plane. The perimeter of the flange 91 ispreferably square shaped. Four walls 95, 97, 99 and 101 upstand from theflange 91, preferably at the perimeter of the flange. Wall 95 is opposedto wall 99, and wall 97 is opposed to wall 101. The four walls 95, 97,99 and 101 are preferably integral with the flange 91 and preferablyeach lie in a plane generally perpendicularly to the flange plane. Thewalls 95, 97, 99 and 01 define an opening 110, discussed in furtherdetail below. A central axis 120 extends through the second piece 90.The central axis 120 is generally perpendicular to the flange plane andgenerally parallel to plane of each wall 95, 97, 99 and 101,respectively.

A hole 96 extends through wall 95. A second hole 98 extends through wall97. A third hole 100 extends through wall 99. A fourth hole 102 extendsthrough wall 101. Each hole 96, 98, 100 and 102 preferably has arespective hole axis that intersects the flange plane at a locationinward of the respective wall, as best shown in FIG. 11. Holes 96, 98,100 and 102 are adapted to receive screws 103. The screws 103 can beselectively turned into or out of the respective holes 96, 98, 100 and102.

Holes 105, 106, 107 and 108 extend through the second piece 90 at theintersection of adjacent walls 95, 97, 99 and 101. Hole 105 is locatedat the intersection of walls 95 and 97. Hole 106 is located at theintersection of walls 97 and 99. Hole 107 is located at the intersectionof walls 99 and 101. Hole 108 is located at the intersection of walls101 and 95. The holes are generally perpendicular to the flange plane.The hole are preferably used to connect the second piece to an adjacentprosthetic component in the conventional manner.

The walls 95, 97, 99 and 101 define an opening 110, as best shown inFIG. 9. The opening is preferably a square shaped opening, having adepth equal to the wall height. The opening has four sides 111, 112, 113and 114. Side 111 is comprised of the inside of wall 95. Side 112 iscomprised of the inside of wall 97. Side 113 is comprised of the insideof wall 99. Side 114 is comprised of the inside of wall 101. Side 111 isopposed to side 113, and side 112 is opposed to side 114.

It is understood that there may be a different number of wallsupstanding from the flange. Specifically, there may be three walls thatform a triangular opening. There may also be more than four walls.Further, there may be only one circular wall. Yet, it has been foundthat having four walls defining a square opening allows for thepreferable combination of high adjustability with minimal weight.

Turning now to FIGS. 12-14, an example of the co-action between thefirst piece 60 and second piece 90 is shown. The positioner 66 of thefirst piece 60 is received within the opening 110 of the second piece90. The body 61 rests atop the top of the walls 95, 97, 99 and 101.Screws 103 received within walls 95, 97, 99 and 101 penetrate theopening 110 to engage the positioner 66. In the preferred embodimentshown, the screw 103 through hole 96 engages face 67 of the pyramidalpositioner 66. Screw 103 through hole 98 engages face 68 of thepyramidal positioner 66. Screw 103 through hole 100 engages face 69 ofthe pyramidal positioner 66. Screw 103 through hole 102 engages face 70of the pyramidal positioner 66. The walls 95, 97, 99 and 101 have aheight that allows a screw 103 to penetrate the opening to engage thepositioner to effectuate the maximum offset amount without contactingthe flange 91.

The central axis 80 of the first piece 60 and the central axis 120 ofthe second piece 90 can be offset by an offset amount beta. The offsetamount beta is comprised of any combination of components from thelateral or medial direction 15 or 16, respectively, and from theanterior or posterior direction 17 or 18, respectively. Describedanother way, the offset amount beta is comprised of a linear amount at acertain angle from the anterior direction 15 (or any other referencedirection). Adjustment of the present invention to achieve a desiredoffset amount beta occurs at a single interface.

It is further seen that the central axis 80 of the first piece 60 andthe central axis 120 of the second piece are generally parallel, evenwhen offset by offset amount beta. In the preferred embodiment, thisparallel alignment is maintained and the overall component isstructurally strengthened by having the body 61 of the first piece 60rest atop the walls 95, 97, 99 and 101 of the second piece. The body 61is preferably a disk shaped flange to ensure that a large portion of thebody 61 contacts the walls while also minimizing the overall weight ofthe component. The preferred disk shape, as shown in FIGS. 12 and 13,also acts to prevent any screws 103 extending out from the second piece90 from being hit, knocked or otherwise damaged.

The preferred geometry of the positioner 66, a pyramid, is shown beingengaged by screws in FIG. 13. The screws 103 force the positioner 66 toremain within the opening due to the pyramidal geometry by forcing thebody 61 to be more tightly held atop the walls 95, 97, 99 and 101 of thesecond piece 90. The tighter the screws 103 engage the positioner 66,the stronger the component 50 is and the greater the component's abilityto maintain the preferred parallel alignment between the first piececentral axis 80 and the second piece central axis 120.

FIGS. 15 and 16 show one application of the present invention used toovercome an offset amount between a socket central axis 12 and thecentral axis of a component attached thereto by an offset amount delta.Even though FIG. 15 only shows two dimensions, the offset amount deltais comprised of a distance in both the lateral or medial direction 15 or16, respectively, and the anterior or posterior direction 17 or 18,respectively. In FIG. 15, the first piece 60 of the present invention isattached to the socket 10.

In order for the central axis 27 of the pylon 25 to be centrally alignedwith the central axis 12 of the socket 10, the second piece 90 must beoffset from the first piece by an offset amount beta that is equal andopposite of the offset amount delta between the socket 10 and the firstpiece 60.

Such adjustment is made at a single interface between the first piece 60and the second piece 90 of the present invention. This is accomplishedin the preferred embodiment by selectively positioning the positioner 66within the opening 110 by selectively turning selected screws a selectedamount into the opening 110 and turning the opposed screw a selectedamount out of the wall to move or reposition the positioner to aselected orientation. This process can be enacted between both sides 111and 113 and sides 112 and 114 to obtain the desired offset amount inboth the lateral or medial direction 15 or 16 and the anterior orposterior direction 17 or 18, respectively.

Turning now to FIGS. 17-26, a second embodiment 150 is shown having twomajor pieces 160 and 190, respectively.

The first piece 160, or component, is shown in further detail in FIGS.18-20. The first piece 160 has a body 161. Body 161 is preferably a flatflange that lies in a plane and that is disk shaped. Body 161 has afirst side 165 and an opposed second side 175. A central axis 185 runsthrough the first piece 160 in a direction generally perpendicular tothe body 161.

A positioner 166 is on the first side 165 of the body 161. Thepositioner 166 is preferably a protrusion that is formed integral withthe first side. Further, the positioner 166 preferably has an insidesurface 167 and an outside surface 168. The outside surface 168 has morethan four faces 169, and in a preferred embodiment has thirty-two faces.Each face is generally planar, with a top at the flange, two sides and abottom remote from the top. The top, bottom and two sides define agenerally rectangular face. Each face is preferably angled approximately7.5 degrees outward away from the central axis 185.

A connector 176 is integral with the second side 175 of the flange. Theillustrated connector 176 is a receiver 177. Yet, it is understood thatother connectors can be used without departing from the broad aspects ofthe present invention so long as is adapted to be connected to anadjacent prosthetic component. The receiver 177 preferably has in inside178 and an outside 179. Holes 180 are through the receiver 177 betweenthe inside 178 and outside 179 for receiving screws. The screws allowfor a protrusion of an adjacent component to be locked within thereceiver.

Turning now to FIGS. 21-23, a second piece 190 is shown in furtherdetail. The second piece 190, or component, has a body 191 shaped as aflange. The flange 191 is preferably flat, and lies in a plane. Theperimeter of the flange 191 is preferably round shaped. The flange 191has a first side 195 and a second side 205.

A receiver 196 is preferably integral with the first side 195 of thebody 191. A preferred receiver 196 is a sidewall 197 that upstands fromthe flange 191, preferably at the perimeter of the flange. The wall 197preferably lies in a plane generally perpendicularly to the flangeplane. The sidewall 197 has an inside surface 198 and an outside surface199. The inside surface 198 preferably has a round geometry with apreferred diameter of approximately 1.5 inches, and defines theperimeter of an opening 203. The sidewall 197 terminates at an end thatlies in a plane generally parallel to the flange 191. The openingpreferably has a depth equal to the wall height, which is preferably0.375 inches. A central axis 215 extends through the second piece 190.The central axis 215 is generally perpendicular to the flange plane.

It is understood that the inside surface 198 can alternatively have morethan four faces, thirty-two for example, rather than a generally roundgeometry without departing from the broad aspects of the presentinvention.

Several holes 200 are through the sidewall 197. Preferably, six holes200 extend through the circular sidewall 197, and are spaced equidistantapart. Each screw hole 200 preferably has an opposite hole half wayaround the inside perimeter of the opening 203 defined by in the insidesurface 198. Screws 201 are provided for being received within the holes200 for being selectively turned into or out of the holes. Each holepreferably has a hole axis that is generally perpendicular to thesidewall and generally parallel to the flange 191.

The second piece 190 also has a second side 205. A connector 206 isintegral with the second side 205 of the flange. The illustratedconnector 206 is a receiver 207. Yet, it is understood that otherconnectors can be used without departing from the broad aspects of thepresent invention so long as is adapted to be connected to an adjacentprosthetic component. The receiver 207 preferably has in inside 208 andan outside 209. Holes 210 are through the receiver 207 between theinside 208 and outside 209 for receiving screws. The screws allow for aprotrusion of an adjacent component to be locked within the receiver.

Turning now to FIGS. 24-26, an example of the co-action between thefirst piece 160 and second piece 190 is shown. The positioner 166 of thefirst piece 160 is received within the receiver opening 203 of thesecond piece 190. The body 161 rests atop the top of end of the sidewall197. Screws 201 received within holes 200 though the sidewall 197penetrate the opening 203 to engage the positioner 166 and lock it intoplace. Opposed screws can be turned in or out, respectively, to lock thepositioner 166 in its desired position. The positioner 166 can fullymove anywhere within the opening 203 defined by the inside surface 198of the sidewall. The screws 200 will not contact the flange 191regardless of the location of the positioner 166 within the opening 203.

The central axis 185 of the first piece 160 and the central axis 215 ofthe second piece 190 can be offset by an offset amount. The offsetamount beta is comprised of any combination of components from thelateral or medial direction 15 or 16, respectively, and from theanterior or posterior direction 17 or 18, respectively. Describedanother way, the offset amount is comprised of a linear amount at acertain angle from the anterior direction 15 (or any other referencedirection). Adjustment of the present invention to achieve a desiredoffset amount beta occurs at a single interface.

It is further seen that the central axis 185 of the first piece 160 andthe central axis 215 of the second piece 190 are generally parallel,even when offset by the offset amount. In the preferred embodiment, thisparallel alignment is maintained and the overall component isstructurally strengthened by having the body 161 of the first piece 160rest atop the sidewall 197 of the second piece 190. The body 161 ispreferably a disk shaped flange to ensure that a large portion of thebody 161 contacts the sidewall 197. It is further seen that the flange161 of the first piece 160 is generally parallel to the flange 191 ofthe second piece 190.

The positioner 166 is held in place in a selected rotatable orientationwithin the opening 203 of the second piece 190. By having more than fourfaces 169, the fist piece 160 can be rotated in increments less than 90degrees relative the second piece 190. With preferably thirty-two faces,the pieces can be adjusted in increments at least as small as 11.25degrees. It is appreciated that as the number of faces 169 increase, thesize of the increments decreases while still maintaining a strong lockon the positioner. Regardless of the rotational orientation of thepositioner 166 within the opening 203, the screws 201 are able to lockthe positioner in place. It is found that three sets of opposing screws,six total, provides acceptable stability. However, it is understood thatmore or less screws 201 could be used without departing from the broadaspects of the present invention.

It is appreciated that the lateral-medial, anterior-posterior, androtational adjustments are made at a single interface between the firstand second pieces, 160 and 190, respectively.

Turning now to FIGS. 27-30, a third embodiment 250 is shown having twomajor pieces 260 and 290, respectively.

The first piece 260, or component, is shown in further detail in FIGS.27-28. The first piece 260 has a body 261. Body 261 is preferably a flatflange that lies in a plane and that is disk shaped. Body 261 has afirst side 265 and an opposed second side 275. A central axis 285 runsthrough the first piece 260 in a direction generally perpendicular tothe body 261.

A positioner 266 is on the first side 265 of the body 261. Thepositioner 266 is preferably a protrusion that is formed integral withthe first side. Further, the positioner 266 preferably has an insidesurface 267 and an outside surface 268. The outside surface 168 has apreferably round perimeter dimension. The outside surfaced 268 ispreferably angled approximately 7.5 degrees outward away from thecentral axis 285.

A connector 276 is integral with the second side 275 of the flange. Theillustrated connector 276 has a dome 277 and a pyramid 278. Yet, it isunderstood that other connectors can be used without departing from thebroad aspects of the present invention so long as is adapted to beconnected to an adjacent prosthetic component.

Turning now to FIGS. 29 and 30, a second piece 290 is shown in furtherdetail. The second piece 290, or component, has a body 291 shaped as aflange. The flange 291 is preferably flat, and lies in a plane. Theperimeter of the flange 291 is preferably square shaped. The flange 291has a first side 295 and a second side 305.

A receiver 296 is preferably integral with the first side 295 of thebody 291. A preferred receiver 296 is a sidewall 297 that upstands fromthe flange 291, preferably at the perimeter of the flange. The wall 297has an end that preferably lies in a plane generally perpendicularly tothe flange plane. The sidewall 297 has an inside surface 298 and anoutside surface 299. The outside surface 299 can have a generally squaregeometry. The inside surface 298 preferably has a round geometry with apreferred diameter of approximately 1.5 inches, and defines theperimeter of an opening 303. The sidewall 297 terminates at an end thatlies in a plane generally parallel to the flange 291. The openingpreferably has a depth equal to the wall height, which is preferably0.375 inches. A central axis 315 extends through the second piece 290.The central axis 315 is generally perpendicular to the flange plane.

Several holes 300 are through the sidewall 297. Preferably, four holes300 extend through the sidewall 297, and are spaced equidistant apart.Each screw hole 300 preferably has an opposite hole half way around theinside perimeter of the opening 303 defined by in the inside surface298. Screws 301 are provided for being received within the holes 300 forbeing selectively turned into or out of the holes.

The second piece 290 also has a second side 305. A connector 306 isintegral with the second side 305 of the flange. The illustratedconnector 306 is a flat surface with four holes 307 there throughforming a four-hole adapter. The holes are at the corners of the flange261 and sidewall 297.

The positioner 266 of the first piece 260 is received within thereceiver opening 303 of the second piece 290. The body 261 rests atopthe top of end of the sidewall 297. Screws received within holes 300though the sidewall 297 penetrate the opening 303 to engage thepositioner 266 and lock it into place. Opposed screws can be turned inor out, respectively, to lock the positioner 266 in its desiredposition. The positioner 266 can move anywhere within the opening 303defined by the inside surface 298 of the sidewall. The screws will notcontact the flange 291 regardless of the location of the positioner 266within the opening 303.

The central axis 285 of the first piece 260 and the central axis 315 ofthe second piece 290 can be offset by an offset amount. The offsetamount is comprised of any combination of components from the lateral ormedial direction 15 or 16, respectively, and from the anterior orposterior direction 17 or 18, respectively. Described another way, theoffset amount is comprised of a linear amount at a certain angle fromthe anterior direction 15 (or any other reference direction). Adjustmentof the present invention to achieve a desired offset amount occurs at asingle interface.

It is further seen that the central axis 285 of the first piece 260 andthe central axis 315 of the second piece 290 are generally parallel,even when offset by the offset amount. In the preferred embodiment, thisparallel alignment is maintained and the overall component isstructurally strengthened by having the body 261 of the first piece 260rest atop the sidewall 297 of the second piece 290. The body 261 ispreferably a disk shaped flange to ensure that a large portion of thebody 261 contacts the sidewall 297. It is further seen that the flange261 of the first piece 260 is generally parallel to the flange 291 ofthe second piece 290.

The positioner 266 is held in place in a selected rotatable orientationwithin the opening 303 of the second piece 290. The round outsidesurface 268 of the fist piece 260 can be rotated in infinitely smallincrements relative the second piece 290. Regardless of the rotationalorientation of the positioner 266 within the opening 303, the screws areable to lock the positioner 266 in place. It is found that four screwsare able to provide acceptable stability. However, it is understood thatmore or less screws could be used without departing from the broadaspects of the present invention.

It is appreciated that the lateral-medial, anterior-posterior, androtational adjustments are made at a single interface between the firstand second pieces, 260 and 290, respectively.

Thus it is apparent that there has been provided, in accordance with theinvention, a four hole offset alignment device that fully satisfies theobjects, aims and advantages as set forth above. While the invention hasbeen described in conjunction with specific embodiments thereof, it isevident that many alternatives, modifications, and variations will beapparent to those skilled in the art in light of the foregoingdescription. Accordingly, it is intended to embrace all suchalternatives, modifications, and variations as fall within the spiritand broad scope of the appended claims.

1. A prosthetic device comprising: a first piece having a central axisand comprising: a flange with a first side and a second side; apositioner integral with said first side of said flange, said positionerhaving an outside surface with a perimeter geometry with one of morethan four faces and round and having a positioner size; and a connectoron said second side of said body for connecting said first piece to afirst prosthetic component, and a second piece connectable to a secondprosthetic component, said second piece having a central axis andcomprising: a flange lying in a plane; and a sidewall upstanding fromsaid flange, said sidewall defining an opening for receiving saidpositioner, said opening having an opening size larger than saidpositioner size, wherein said flange of said first piece contacts saidsidewall of said second piece when said positioner is received withinsaid opening, and wherein with respect to said second piece, said firstpiece is selectively and adjustable in all directions within saidopening while maintaining a parallel relationship of said central axisof said first piece and said central axis of said second piece, and alsorotatably adjustable at increments less than 90 degrees.
 2. Theprosthetic device of claim 1 wherein said outside surface of saidpositioner is comprised of more than four faces.
 3. The prostheticdevice of claim 2 wherein said outside surface of said positioner iscomprised of thirty-two faces.
 4. The prosthetic device of claim 1wherein said outside surface of said positioner is comprised of a roundface.
 5. The prosthetic device of claim 1 wherein said positioner has aninside surface defining a hollow portion of said positioner.
 6. Theprosthetic device of claim 1 wherein said sidewall has a generally roundinterior dimension.
 7. The prosthetic device of claim 6 wherein saidsidewall has six holes therethrough for receiving screws to lock saidpositioner within said opening.
 8. The prosthetic device of claim 1wherein said flange of said first piece is generally parallel to saidflange of said second piece.
 9. A prosthetic device comprising: a firstpiece having a central axis and comprising: a flange with a first sideand a second side and defining a plane; a positioner integral with saidfirst side of said flange, said positioner having a positioner geometrywith one of more than four faces and round and having a positioner size;and a connector on said second side of said body for connecting saidfirst piece to a first prosthetic component, and a second piececonnectable to a second prosthetic component, said second piece having acentral axis and comprising: a flange lying in a plane; and a sidewallupstanding from said flange, said sidewall defining an opening forreceiving said positioner, said opening having an opening size largerthan said positioner size, wherein said flange of said first piececontacts said sidewall of said second piece when said positioner isreceived within said opening, and wherein with respect to said secondpiece, said first piece is selectively and adjustable in all directionswithin said opening and rotatably adjustable at increments less than 90degrees, and said plane of said flange of said first piece remainsgenerally parallel to and equally offset from said flange of said secondpiece during said adjustments.
 10. The prosthetic device of claim 9wherein said outside surface of said positioner is comprised of morethan four faces.
 11. The prosthetic device of claim 10 wherein saidoutside surface of said positioner is comprised of thirty-two faces. 12.The prosthetic device of claim 9 wherein said outside surface of saidpositioner is comprised of a round face.
 13. The prosthetic device ofclaim 9 wherein said positioner has an inside surface defining a hollowportion of said positioner.
 14. The prosthetic device of claim 9 whereinsaid sidewall has a generally round interior dimension.
 15. Theprosthetic device of claim 14 wherein said sidewall has six holestherethrough for receiving screws to lock said positioner within saidopening.
 16. The prosthetic device of claim 9 wherein said flange ofsaid first piece is generally parallel to said flange of said secondpiece.
 17. A prosthetic device comprising: a first piece having acentral axis and comprising: a flange with a first side and a secondside and defining a plane; a positioner integral with said first side ofsaid flange, said positioner having an external surface with more thanfour faces along an external perimeter; and a connector on said secondside of said body for connecting said first piece to a first prostheticcomponent, and a second piece connectable to a second prostheticcomponent, said second piece having a central axis and comprising: aflange lying in a plane; and a sidewall upstanding from said flange,said sidewall defining an opening for receiving said positioner, saidopening having an opening size larger than said external perimeter ofsaid positioner, wherein said flange of said first piece contacts saidsidewall of said second piece when said positioner is received withinsaid opening, and wherein with respect to said second piece, said firstpiece is selectively and adjustable in all directions within saidopening and rotatably adjustable at increments less than 90 degrees, andsaid plane of said flange of said first piece remains generally parallelto and equally offset from said flange of said second piece during saidadjustments.
 18. The prosthetic device of claim 17 wherein saidpositioner has thirty-two faces.
 19. The prosthetic device of claim 18wherein said positioner has an interior surface defining a hollowinterior of said positioner.
 20. The prosthetic device of claim 17wherein said sidewall has six holes therethrough for receiving screws tolock said positioner within said opening.